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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database
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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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To sort by data column: 26 orders  
  Active Orders
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Sort By 522 Order Number 522
Order
Number		 Sort By 522 Order Number -- Descending
Sort By Manufacturer Manufacturer Sort By Manufacturer -- Descending
   Sort By Device Name Device
Name		 Sort By Device Name -- Descending
Medical
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Sort By Date 522 Order Date 522
Order		 Sort By Date 522 Order -- Descending
Study
Name
Date Original
Plan
Accepted
Study Status
PS210001 Abbott Diabetes Care Inc. Freestyle libre 2 flash glucose monitoring system Clinical Chemistry 02/18/2021 Postmarket Surveillance 05/25/2021 Progress Inadequate
PS120001 Acell, Inc. Acell matristem pelvic floor matrix General &
Plastic Surgery		 01/03/2012 POP AE and Effectiveness rates, registry 09/08/2013 Progress Adequate
PS140001 Argo Medical Technologies, Inc Rewalk Neurology 06/26/2014 ReWalk Registry 05/05/2016 Revised/Replaced Study
ReWalk RWE Study 03/09/2020 Progress Adequate
PS200001 Avenu Medical, Inc. Ellipsys vascular access system 01/10/2020 Ellipsys Vascular Access System PS Study 05/29/2020 Progress Adequate
PS160001 Bayer Healthcare, LLC Essure system for permanent birth control Obstetrics/
Gynecology		 02/29/2016 Postmarket Surveillance Study 09/02/2016 Progress Adequate
PS200004 Bluegrass Vascular Technologies, Incorporated Surfacer inside-out access catheter system 02/10/2020 Postmarket Surveillance Study 02/22/2021 Study Pending
PS200005 Caldera Medical, Inc. Desara One Single Incision Sling System Gastroenterology/
Urology		 02/11/2020 Postmarket Surveillance Study 06/05/2020 Progress Inadequate
PS130039 Coloplast Corp Altis single incision sling system Gastroenterology/
Urology		 03/13/2013 AE and effectiveness rates 12/06/2013 Progress Adequate
PS120106 Coloplast Corp. Restorelle polypropylene mesh General &
Plastic Surgery		 04/09/2012 POP AE and Effectiveness rates, registry 05/17/2013 Progress Adequate
PS150002 Fujifilm Medical Systems USA, Inc. Fujifilm duodenoscopes Gastroenterology/
Urology		 10/05/2015 Sampling and Culturing Study 12/21/2016 Noncompliant
PS190002 FUJIFILM Medical Systems, U.S.A., Inc. Duodenoscope Gastroenterology/
Urology		 08/28/2019 Sampling and Culturing 01/24/2020 Progress Adequate
PS200006 Medtronic, Inc. Carpediem 04/29/2020 CARPEDIEM 522 10/01/2020 Progress Adequate
PS110070 MicroPort Metal transcend articulation system Orthopedic 05/06/2011 Metal Ion Levels Microport 01/30/2017 Progress Inadequate
Explant 03/21/2017 Progress Inadequate
Metal Ion Levels Wright 11/01/2012 Revised/Replaced Study
PS110002 Nexus CMF Tmj fossa-eminence/condylar prosthesis system Dental 02/04/2011 Registry Database 08/23/2013 Revised/Replaced Study
TMJM Registry Study - Partial 03/16/2016 Revised/Replaced Study
Prospective Postmarket Surveillance Study Plan 02/04/2011 Progress Inadequate
Explant Analysis Study Plan 02/04/2011 Progress Adequate
PS200003 Olympus America, Inc. Evis exera iii duodenovideoscope tjf-q190v Gastroenterology/
Urology		 01/17/2020 Sampling and Culturing Study 04/17/2020 Progress Adequate
PS150003 Olympus Medical Systems Corporation (OMSC. Duodenoscopes Gastroenterology/
Urology		 10/05/2015 Sampling and Culturing Study 11/22/2016 Noncompliant
PS200007 Outset Medical Inc. Tablo hemodialysis system Gastroenterology/
Urology		 06/12/2020 Human Factors Study 03/05/2021 Study Pending
PS160003 Parker Hannifin Corporation Indego Neurology 04/15/2016 Indego Postmarket Surveillance Study 10/07/2016 Progress Inadequate
PS210002 Pentax PENTAX ED32-i10 Duodenoscope Gastroenterology/
Urology		 04/01/2021 Postmarket Surveillance (PS) Study 06/17/2021 Progress Adequate
PS150004 Pentax Medical Duodenoscopes Gastroenterology/
Urology		 10/05/2015 Sampling and Culturing Study 12/08/2016 Progress Adequate
PS190005 Pentax of America, Inc. Pentax duodenoscope model ed34-il0t2 Gastroenterology/
Urology		 11/15/2019 Sampling and Culturing Study 02/13/2020 Progress Adequate
PS190001 Rapid-Medical, Ltd. Comaneci embolization assist device 05/22/2019 Success in Comaneci-assist Coils Embolization Surv 08/06/2020 Progress Adequate
PS190006 Tandem Diabetes Co. Control-iq, algorithm 12/13/2019 Postmarket Surveillance Study 04/30/2020 Progress Adequate
PS200008 Tandem Diabetes Co. Control-IQ Technology Clinical Chemistry 06/23/2020 PSS Plan Overdue
PS110003 TMJ Concepts Patient-fitted tmj reconstruction prosthesis system Dental 02/04/2011 Time to Revision and Explant Analysis 01/13/2012 Progress Adequate
PS180002 TVA Medical, Inc. Everlinq endoavf system 06/22/2018 EverlinQ endoAVF 11/06/2020 Study Pending


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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